Abstract
This randomized controlled trial investigated the safety and efficacy of MF4637, a high concentrate omega-3 fatty acid preparation, in correcting the omega-3 fatty acid nutritional deficiency in non-alcoholic fatty liver disease (NAFLD). The primary end point of the study was set as the change of red blood cell (RBC) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) by MF4637. Whether the omega-3 concentrate could lower liver fat was evaluated in a subset of patients. Furthermore, 176 subjects with NAFLD were randomized to receive the omega-3 concentrate (n = 87) or placebo (n = 89) for 24 weeks, in addition to following standard-of-care dietary guidelines. The omega-3 index, omega-6: omega-3 fatty acid ratio and quantitative measurements of RBC EPA and DHA were determined at baseline and study completion. Magnetic resonance imaging of liver fat was conducted in a subset of patients. Administration of high concentrate omega-3 for 24 weeks significantly increased the omega-3 index and absolute values of RBC EPA and DHA, and decreased the RBC omega-6: omega-3 fatty acid ratio (p < 0.0001). A significant reduction in liver fat content was reported in both groups.
Highlights
Non-alcoholic fatty liver disease (NAFLD) is the presence of hepatic steatosis (>5% liver fat assessed by imaging modalities or >5% of cells containing visible lipid droplets from histology) that is not related to significant alcohol consumption, hereditary disorders, viral infection or steatogenic medication [1]
This study demonstrates that intervention with high concentrate omega-3 for 24 weeks significantly raises the omega-3 index and decreases the omega-6: omega-3 fatty acid ratio in adults with NAFLD
The current randomized placebo-controlled study supports the use of omega-3 supplementation to increase the omega-3 index in NAFLD patients, significantly greater than that obtained by dietary recommendation alone
Summary
Non-alcoholic fatty liver disease (NAFLD) is the presence of hepatic steatosis (>5% liver fat assessed by imaging modalities or >5% of cells containing visible lipid droplets from histology) that is not related to significant alcohol consumption, hereditary disorders, viral infection or steatogenic medication [1]. NAFLD is typically reversible, but can develop in some 30% of cases into non-alcoholic steatohepatitis (NASH), presenting as hepatic steatosis with inflammation, ballooning and evidence of hepatocellular injury with or without fibrosis [1,2,3]. NAFLD is estimated to affect 20–30% of the general population, with the prevalence increasing to approximately 75% of patients with obesity or diabetes, and 90–95% in the Nutrients 2018, 10, 1126; doi:10.3390/nu10081126 www.mdpi.com/journal/nutrients. The estimated prevalence of NASH is lower, but significant, at 2–3% of the general population and one-third of the morbidly obese [1,7]
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